Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00474006
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2007-05-15
Brief Title:
High Dose Daunorubicin Vs Standard Dose Daunorubicin in Induction Treatment of AML
Sponsor:
Cooperative Study Group A for Hematology
Organization:
Cooperative Study Group A for Hematology
Study Overview
Official Title:
A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADcomparison
Brief Summary:
Determine the effects of escalated dose of daunorubicin in induction treatment of adult patients with acute myelogenous leukemia who are younger than 60 years of age
Detailed Description:
1 Induction chemotherapy
For patients randomized to receive regular dose of Daunorubicin Arm I will be given Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 45 mgm2day by continuous iv infusion over 24 hours daily for 3 days
For patients randomized to receive higher dose of Daunorubicin Arm II will be given Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 90 mgm2day by continuous iv infusion over 24 hours daily for 3 days
2 Reinduction chemotherapy
Bone marrow aspiration and biopsy will be performed on day 14 of induction chemotherapy If the bone marrow is hypoplastic and contains no more than 5 blast cells further chemotherapy will be deferred and the marrow examination will be repeated at the time of ANC 1500μl and platelets 100000μl in the peripheral blood for the evaluation of complete remission If more than 5 blast cells persist or if the marrow cellularity in the biopsy specimen exceeds 15 a course of reinduction chemotherapy will be given
Reinduction chemotherapy consists of Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 5 days along with Daunorubicin 45 mgm2day by continuous iv infusion over 24 hours daily for 2 days in both arms
3 Postremission therapy
The same postremission therapy will be given to the patients in both arms
Four courses of Cytarabine 3 gm2 will be administered in a 3-hour iv infusion every 12 hours twice daily on days 1 3 and 5 for a total of six doses per course After the four courses of Cytarabine therapy patients will receive two monthly treatments with Cytarabine 200 mgm2day by a 3-hour iv infusion for 5 days and Daunorubicin 45 mgm2 by rapid iv infusion on the first treatment day
If patients have HLA-matched sibling or unrelated donors allogeneic stem cell transplantation will be performed
A complete remission will be defined as 5 blasts in a normocellular bone marrow with ANC 1500μl and platelets 100000μl in the peripheral blood and the disappearance of all blasts in bone marrow
For patients randomized to receive regular dose of Daunorubicin Arm I will be given Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 45 mgm2day by continuous iv infusion over 24 hours daily for 3 days
For patients randomized to receive higher dose of Daunorubicin Arm II will be given Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 7 days along with Daunorubicin 90 mgm2day by continuous iv infusion over 24 hours daily for 3 days
2 Reinduction chemotherapy
Bone marrow aspiration and biopsy will be performed on day 14 of induction chemotherapy If the bone marrow is hypoplastic and contains no more than 5 blast cells further chemotherapy will be deferred and the marrow examination will be repeated at the time of ANC 1500μl and platelets 100000μl in the peripheral blood for the evaluation of complete remission If more than 5 blast cells persist or if the marrow cellularity in the biopsy specimen exceeds 15 a course of reinduction chemotherapy will be given
Reinduction chemotherapy consists of Cytarabine 200 mgm2day by continuous iv infusion over 24 hours daily for 5 days along with Daunorubicin 45 mgm2day by continuous iv infusion over 24 hours daily for 2 days in both arms
3 Postremission therapy
The same postremission therapy will be given to the patients in both arms
Four courses of Cytarabine 3 gm2 will be administered in a 3-hour iv infusion every 12 hours twice daily on days 1 3 and 5 for a total of six doses per course After the four courses of Cytarabine therapy patients will receive two monthly treatments with Cytarabine 200 mgm2day by a 3-hour iv infusion for 5 days and Daunorubicin 45 mgm2 by rapid iv infusion on the first treatment day
If patients have HLA-matched sibling or unrelated donors allogeneic stem cell transplantation will be performed
A complete remission will be defined as 5 blasts in a normocellular bone marrow with ANC 1500μl and platelets 100000μl in the peripheral blood and the disappearance of all blasts in bone marrow
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None